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Sermorelin, Growth Hormone Releasing Hormone (1-29), hGRF(1-29)NH2

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Overview Studies Clinical Trials

Completed PHASE3 INTERVENTIONAL NCT01419197

A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in participants with metastatic or unresectable locally advanced/recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Eligible participants will be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days or treatment of the physician's choice. Participants continue to receive study treatment until disease progression or unacceptable toxicity occurs. This study is also known under Roche study protocol number BO25734.

Interventions

Name: Trastuzumab emtansine

Type: DRUG

Description: The dose was calculated based on the patient's Baseline weight on Day 1 of each 3-week treatment cycle. The same dose was administered in subsequent cycles if the patient's weight stayed within 10% of the Baseline weight. If there was a weight change \> 10%, the dose was adjusted accordingly and the recorded weight became the new Baseline weight. Trastuzumab emtansine was provided as a single-use lyophilized formulation.

Name: Treatment of physician's choice

Type: DRUG

Description: The treatment of physician's choice (TPC) was a protocol-specified approved or standard of care therapy or combination of therapies, based on frequently used regimens for late-line HER2-positive metastatic breast cancer treatment after receipt of both trastuzumab- and lapatinib-containing regimens. The therapies included single-agent chemotherapy, single-agent (e.g., tamoxifen or aromatase inhibitor) or dual-agent (e.g., aromatase inhibitor with luteinizing hormone releasing hormone \[LHRH\] agonist) hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy. Participants who had documented progressive disease (PD) were eligible to switch treatment to receive trastuzumab emtansine 3.6 mg/kg. Participants who switched treatment remained on trastuzumab emtansine treatment until another PD event or unmanageable toxicity. The formulation, storage, and preparation of all TPC were as per the appropriate package insert or national prescribing information.

Primary Outcomes

Measure: Progression-free Survival

TimeFrame: Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)

Description: Progression-free survival was defined as the time from randomization to the first documented disease progression by investigator assessment using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurred first. Progression-free survival was a co-primary endpoint.

Measure: Overall Survival

TimeFrame: Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)

Description: Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was a co-primary endpoint.

Trial Information

NCT ID

NCT01419197

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Hoffmann-La Roche

Last Updated

December 15, 2025